This position reports directly to the Director of Technical Services. The role is responsible for general support of the cGMP manufacturing operations and Technical Services department. The position will be responsible for the authoring of SOPs, batch records and protocols. The role may support the stability program and other technical services initiatives.
• Generate, revise, and review SOP’s and procedures used for production batch operations as well as maintaining records to comply with regulatory requirements and cGMPs.
• Create and publish technical documentations and manuals.
• Collect technical data or information and coordinate documentation and procedures.
• Assist with inspection preparation activities, protocol and report writing, project coordination, continuous improvement efforts to improve process robustness and efficiency, and other related Technical Services tasks.
• Assist investigations, data collection, and CAPA actions in the department. Work with production to quickly resolve any variance or deviations so that quality product is manufactured, as needed.
• Assist in organizational tasks and other duties as assigned for the stability program.
EXPERIENCE AND NECESSARY SKILLS:
• Ability to interface effectively with management personnel across manufacturing, quality, engineering and other technical disciplines.
• Ability to work independently, as a member of a team (including matrixed organizational structures), and to work with external contractors to meet project needs and timelines.
• Knowledge of cGMP guidelines/regulations preferred.
• High School Diploma required; Bachelor’s degree preferred.
• Demonstrated written and oral communications skills.
• Excellent organizational skills.
• Results oriented.
• Strong Microsoft Office skills with proficiency in the use of spreadsheets and word processing programs.